Methods and devices for reducing pressure

ABSTRACT

The disclosure provides device and related methods that can be used to treat edema by applying pressure to a blood vessel such as a jugular vein to restrict flow therein, creating a local decrease in blood pressure within the jugular vein near an outlet of a lymphatic duct, causing lymph to drain from the interstitium.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/473,420, filed Mar. 19, 2017, the contents of which are incorporatedby reference.

TECHNICAL FIELD

The disclosure relates to heart failure and edema.

BACKGROUND

Heart failure, often referred to as congestive heart failure (CHF),occurs when the heart is unable to pump sufficiently to maintain bloodflow to meet the body's needs. A person suffering heart failure mayexperience shortness of breath, exhaustion, and swollen limbs. Heartfailure is a common, costly, and potentially fatal condition. In 2015 itaffected about 40 million people globally with around 2% of adultsoverall having heart failure. As many as 10% of people over the age of65 are susceptible to heart failure.

In heart failure, the pressures in the heart ventricles and atria areexcessively elevated. As a result, the heart works harder to ejectblood, leading to a buildup of blood pressure, which may result in edemaforming within interstitial compartments of the body. Edema refers tothe abnormal accumulation of fluid in tissues of the body and resultswhen elevated blood pressure prevents lymphatic fluid from draining fromthe interstitium. The additional work of the heart, with time, weakensand remodels the heart thus further reducing the ability of the heart tofunction properly. The fluid accumulation leads to dyspnea and acutedecompensated heart failure (ADHF) hospitalization. Those conditions mayresult in severe health consequences including death.

SUMMARY

The disclosure provides device and related methods that can be used totreat edema by applying pressure to a blood vessel such as a jugularvein to restrict flow therein, creating a local decrease in bloodpressure within the jugular vein near an outlet of a lymphatic duct,causing lymph to drain from the interstitium. A device for applyingpressure may have the form of a neck cuff or similar, with an extendedcollar member that may extend around a neck of a patient, with aprojection protruding inward from an inner surface of the collar memberto press against the neck near the jugular vein, restricting blood flowwithin the jugular vein. Thus, the disclosure provides methods anddevices for reducing pressure within the heart ventricle and as a resultin the venous system and in the lymphatic outflow.

In certain aspects, the invention provides a device for treating edema.The device includes an extended collar member dimensioned to extend atleast partway around a neck of a patient and a projection protrudinginward from an inner surface of the collar member. The projection ispositioned to press against the neck near a jugular vein, therebyrestricting blood flow within the jugular vein. The extended collarmember may be in the form of a neck cuff that fastens around the neck.The neck cuff may include an elongated, flexible strap with anadjustable fastening mechanism that allows the strap to be fastened intoa closed loop at any of a plurality of circumferences. The projectionmay be provided as an elastic pad seated in the strap.

In some embodiments, the device includes a screw threaded through aportion of the collar member, wherein the projection is provided by atip of the screw. Twisting a head of the screw when the extended collarmember is disposed about the neck of the patient drives the projectioninto the neck to restrict flow within the jugular vein. The tip of thescrew may include an elastic pad that, when the screw is tightened,restricts flow within the jugular vein. Restricting the flow within thejugular vein causes pressure near an outlet of a lymphatic duct todecrease.

In certain embodiments, the extended collar member includes a C-shapedsemi-ring that extends about halfway around the neck. The semi-ring mayinclude at least a first tang fastened at a first end of the semi-ringand extending therefrom. A screw may be threaded through the first tang,such that the projection is provided as an elastic pad disposed over aninner tip of the screw. An outer base of the screw may have wide head,e.g., textured or knurled for manipulation. Preferably, twisting thewide head of the screw when the extended collar member is disposedaround the neck of the patient drives the elastic pad into the neck torestrict flow within the jugular vein. The semi-ring may also have asecond tang fastened at a second end of the semi-ring and extendingtherefrom, the second tang having a second screw threaded therethrough.Thus, the extended collar member may include a rigid C-shaped semi-ringthat extends at least partially around the neck, the semi-ring having atleast a first tang extending from a first end of the semi-ring, whereinthe projection protrudes inward from an inner surface of the first tang.

In some embodiments, the projection includes an inflatable pad.Inflating the pad when the extended collar member is disposed around theneck of the patient drives the pad into the neck to restrict flow withinthe jugular vein.

In certain embodiments, the extended collar member extends at leastpartially around the neck, and at least a portion of the collar memberis inflatable, such that inflating the portion when the collar member isdisposed around the neck of the patient drives the projection into theneck to restrict flow within the jugular vein.

In some embodiments, the extended collar member includes a releasablefastening mechanism defining a plurality of stops corresponding toprogressively tighter fittings, wherein cinching the extended collarmechanism closed drives the projection into the neck to restrict flowwithin the jugular vein.

In related aspects, the disclosure provides a method of draining lymph.The method includes restricting flow through a jugular vein of a patientby applying pressure to a neck of the patient at a spot on the neckproximal to the jugular vein, thereby decreasing pressure at an outflowof a lymphatic duct. Methods may be used for reducing the pressureswithin the heart, especially during its diastolic phase, which mayimprove filling pattern of the ventricle and enable the AV valve to openat a later time in the isovolumetric relaxation phase of the heartcycle. That could in turn improve contractility of the heart.Furthermore, reducing the pressures during the diastolic phase, which isabout 75% of the cardiac cycle, reduces the pressures throughout thevenous system, thereby alleviating the edema formed by high venous andleft ventricular filling pressures present in heart failure patients andin ADHF patients. The reduction of pressures in the venous system willin turn enhance lymphatic return because the outflow pressure in thethoracic and lymphatic ducts will be reduced. The thoracic duct emptiesinto the venous system and in heart failure patients the central venouspressure (CVP) is high and therefore the lymphatic return is not as highas it could be if the CVP was reduced.

Methods of the disclosure are preferably used with a patient affected byheart failure or edema. Embodiments of the methods include applying thepressure to the spot on the neck by making contact between the spot onthe neck and a medical device for treating edema. In some embodiments,methods use a device that includes an extended collar member dimensionedto extend at least partway around the neck with projection protrudinginward from an inner surface of the collar member, the projectionpositioned to press against the spot on the neck.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a device for treating edema.

FIG. 2 is a top view of the neck brace device.

FIG. 3 is a side view of the device.

FIG. 4 diagrams a method of draining lymph.

FIG. 5 shows a treatment device with screws.

FIG. 6 shows the device with screws around the neck of a patient.

FIG. 7 is a close-up of the device with screws.

FIG. 8 shows an elastic pad of the device with screws.

FIG. 9 depicts a patient being treated with the device with screws.

FIG. 10 shows a disc-based device.

FIG. 11 shows the disc-based device on a patient.

FIG. 12 is a detailed view of the disc-based device.

FIG. 13 is a detail view of a screw and disc of the disc-based device.

FIG. 14 shows a balloon device.

FIG. 15 shows the balloon device around the neck of a patient.

FIG. 16 shows the balloon device on the patient.

FIG. 17 is a detailed view of the balloon device.

FIG. 18 shows an inflatable pad.

FIG. 19 shows an inflatable collar device.

FIG. 20 shows the inflatable collar device on a patient.

FIG. 21 shows positioning for the inflatable collar device.

FIG. 22 shows a projection member of the inflatable collar device.

FIG. 23 shows a tightening cuff style fastening device.

FIG. 24 shows the tightening cuff style device in place.

FIG. 25 shows a tightening-cuff on a patient

FIG. 26 shows a projection included in the tightening cuff style device.

FIG. 27 shows a limb-cuff device for reducing the CVP.

FIG. 28 shows a patient with the limb-cuff device.

FIG. 29 shows the limb cuff device disposed with respect to a femoralvein.

FIG. 30 is a close-up of the limb cuff device on a patient.

FIG. 31 shows a projection member included on an inner surface of thelimb cuff device.

FIG. 32 shows a deployable stent device.

FIG. 33 shows the deployable stent device in a deployed configuration.

FIG. 34 shows an open-sheath device for treating edema.

FIG. 35 shows the restriction device in a jugular vein.

FIG. 36 shows the restriction device.

FIG. 37 is a close-up of the balloon of the restriction

FIG. 38 is a cross section along and through the restriction device.

FIG. 39 is a cross-section across the catheter shaft of the restrictiondevice.

FIG. 40 shows the restriction device in vasculature of a patient.

FIG. 41 is a close up of the restriction device in the patient.

FIG. 42 illustrates a collapsible tube device for treating edema.

FIG. 43 shows the balloon of the collapsible tube device.

FIG. 44 shows the collapsible tube device located within a vessel of apatient.

FIG. 45 graphs central venous pressure (CVP).

FIG. 46 illustrates elevated CVP.

DETAILED DESCRIPTION

The disclosure provide devices and methods for reducing the pressureswithin the heart especially during its diastolic phase to provideimproved filling pattern of the ventricle and enable the AV valve toopen at a later time in the isovolumetric relaxation phase of the heartcycle. This may in turn improve contractility of the heart. Furthermore,reducing the pressures during the diastolic phase, which is about 75% ofthe cardiac cycle, may reduce the pressures throughout the venous systemand thus alleviate the edema formed as a result of the excessively highvenous and left ventricular filling pressures present in heart failurepatients and in ADHF patients. The reduction of pressures in the venoussystem will in turn enhance lymphatic return because the outflowpressure in the thoracic and lymphatic ducts will be reduced. Thethoracic duct empties into the venous system and in heart failurepatients the central venous pressure (CVP) is high and therefore thelymphatic return is not as high as it could be if the CVP was reduced.

FIG. 1 shows a device 101 for treating edema, positioned with respect toan external jugular vein 2191 and an internal jugular vein 2192. Thedevice 101 includes an extended collar member dimensioned to extend atleast partway around a neck of a patient and a projection protrudinginward from an inner surface of the collar member. The collar member maybe provided as a strap 109. The projection is positioned to pressagainst the neck near a jugular vein, thereby restricting blood flowwithin the jugular vein.

FIG. 2 is a top view of the neck brace device 101. Preferably, the neckcuff comprises an elongated, flexible strap 109 with an adjustablefastening mechanism 115 that allows the strap to be fastened into aclosed loop at any of a plurality of circumferences. The device 101includes a projection in the form of an elastic pad 121 seated in thestrap 109.

FIG. 3 shows a side view of the neck brace device 101. The device 101 isuseful for reducing the pressure in the outflow of the lymphatic ductsand by that enhancing lymphatic return in fluid overloaded patients. Inthe depicted embodiment, the extended collar member forms a neck cuffthat fastens around the neck.

FIG. 4 diagrams a method 401 of draining lymph. The method 401 includespositioning 405 a device at a neck of a patient. The method 401 mayinclude imaging 411 the treatment location using a medical imaginginstrument or technique such as ultrasound (US). The method 401 includesapplying 415 pressure to a neck of the patient at a spot on the neckproximal to the jugular vein. This results in restricting 419 flowthrough a jugular vein of a patient by thereby decreasing pressure at anoutflow of a lymphatic duct. As a result, lymph will drain 423 from thelymphatic system to the circulatory system. Preferably, the method 401is used to treat a patient affected by heart failure or edema.

In some embodiments, applying 415 the pressure includes making contactbetween the spot on the neck and a medical device for treating edema,such as the device 101. The method 401 employs the functionality bywhich the heart is a suction pump that is constantly trying to preservecardiac output. As such when the right atrium and ventricle detect areduction or restriction in the return of blood to the right heartduring the diastolic phase, the heart muscle will create more negativepressures in an attempt to compensate and pull in the required bloodvolume and maintain blood flow. Those phenomena of the heart are notnecessarily impeded in heart failure patients but if they are impededthey still exist in a lesser extent. Nearly half of all patients withheart failure have a normal ejection fraction (EF). The prevalence ofthis syndrome, termed heart failure with preserved ejection fraction(HFpEF), continues to increase in the developed world, likely because ofthe increasing prevalence of common risk factors, including older age,female sex, hypertension, metabolic syndrome, renal dysfunction andobesity.

In heart failure patients, the systolic function can be impaired, thediastolic volume can be impaired in HFpEF patients but the basic abilityof the heart muscle to create these negative pressures during thediastolic phase (if the return of blood to the atria is reduced) canstill be functional. As a result of the suction mechanism of the rightventricle the overall venous pressure and central venous pressure (CVP)will be reduced as the venous system is directly connected to the rightventricle and atria during the diastole phase. The reduction of the CVP,when the heart increases its suction forces, can lead to improvedmedical condition in pathologies such as ADHF, reduced kidneyfiltration, edema, lymphedema, and lymphatic flow. All those pathologiesrely on normal CVP in order to function optimally. For example, thereduced CVP will reduce the pressure at the lymphatic outflow both inthe thoracic duct and the lymphatic duct. The method 401 may be usefulto enhance the lymphatic return and alleviate edema that accompaniesmost of ADHF hospitalizations.

The method 401 may also reduce the pressures in the renal vein and inthe rest of the venous system and thus alleviate the edema by allowinginterstitial fluid to return into the venous system and in the lymphnodes, as well. Reducing the venous pressure in the renal vein canimprove renal flow and thus improve renal function. Thus the disclosureprovides devices, systems and methods for achieving those benefits,which devices, systems, and methods may be very beneficial for patients.

One way for achieving the suction effect of the heart and reduce itsdiastolic pressures can be to partially restrict the flow in any of themajor veins such as the right or left jugular, right or left subclavian,femoral veins, or the inferior vena cava (IVC). The partial flowrestriction can be achieved in several ways including but not limited tointravenous, extra venous, and transcutaneous devices which act to limitfluid flow. In some embodiments, a device is placed in or on a patient,activated and any level of restriction from full to partial restrictionis achieved. As a result, the pressures in the venous system will bereduced and ADHF patients can be treated to alleviate the edema via boththe lymphatic and venous systems drainage of interstitial edema.

As one example of a device of the disclosure, a transcutaneous device101 for reducing CVP pressure is provided. The device 101 provides anexternally applied compression probe that may be located on thepatient's skin directly adjacent to a target vessel such as one of theinternal jugular veins (IJVs). The right or left internal jugular veinsare commonly accessed using the Seldinger technique on the left or rightside of the patient's neck for the placement of central venouscatheters. A needle and guidewire are advanced through patient's skininto the jugular vein and then a central venous catheter is advancedover the wire either posteriorly or proximally. Here, the compressionprobe (e.g., device 101) is applied in contact with the skin on thepatient's neck. A portion of the compression probe consists of tip 121which focally compresses the tissue adjacent to the target vessels (e.g. internal jugular) thereby effecting compression of the target vesselthereby reducing distal flow and pressure.

Since the left and right jugular vein are usually in close proximity tothe carotid artery the device compression probe tip could have the formof a small hemi balloon inflated to say 40 mm Hg. Such a balloon wouldcompress and occlude the jugular vein having typical pressure of <30 mmHg without occluding the carotid (which would be extended by arterialblood pressure running upwards of 70 mm Hg). The compression probe canbe made form a biocompatible material for example silicon and the rateof jugular constriction can be regulated by ultrasound visualization ofthe jugular and a confirmation of the pressure reduction by measuringthe baseline and after restriction diameter of the opposite internaljugular. Once the probe compresses as desired the collar is then fixedin place and the restriction is maintained throughout the period of thetreatment.

To target such a compression probe, ultrasound could be used in the samemanner as for determining the site for a needle penetration forplacement of a central line. Alternatively, the subject invention couldinclude an ultrasound array integrated into the device. Such an arraywould enhance accuracy of device placement and also provide capabilityto monitor pressure and flow distal to the pressure tip.

The pressure probe may be mounted in something like a collar or harnessto keep it in place for a considerable time, and the probe may beadvanced carefully by one of several means, (e. g. adjustable screwthread or secondary pressure balloon). The compression probe balloonpressure could be displayed on a pressure gage that could be observed asthe probe is advanced until an appropriate pressure was achieved (30-70mm Hg). Devices of the disclosure may also include an integratedpressure/flow sensor (e.g. via ultrasound) which would allow dynamicclosed loop adjustment of the compression probe to achieve the desiredflow reduction. For example, the compression probe could be cycled onand off at varying intervals to vary the flow restriction and flowreduction and to further allow periods of normal flow.

In related embodiments, the restriction is achieved by a pressing on thefemoral vein, similarly as may be done for the jugular vein. Devices andmethods of the disclosure may also be used with intravascular edemacatheters such as those disclosed in WO 2015/186003; WO 2015/186005; WO2016/181217; U.S. Pub. 2017/0197021; and U.S. Pub. 2016/0331378,incorporated by reference.

The following approach may be suitable or preferable for someapplications. As an example of an extravascular flow restrictor, acompression device can be advanced through the patient's skin to a sitelocated adjacent the target vessel. The tip of the transcutaneous probeselectively applies pressure to the vessel. In one embodiment, theextravascular probe tip consists of an inflatable balloon.

Another extravascular flow restrictor comprises a compression cuff whichis placed around the target vessel. Such a device could be placedsurgically, percutaneously, or using minimally invasive techniques. Aballoon element in the collar would allow selective compression of thetarget vessel, much like a blood pressure cuff. For patients thatfrequently suffer from pulmonary edema, such a device could consist of along-term implant which can be activated by an implantable controller,much like a pacemaker, to adjust venous pressure as needed or prescribedby a physician.

The following embodiments may be useful for reducing the pressures byapplying external forces that restrict the jugular vein flow.

FIG. 5 shows a screw-based device 501 that includes collar pressuremechanism using screws. The device 501 includes an extended collarmember 515 dimensioned to extend at least partway around the neck and aprojection 537 protruding inward from an inner surface of the collarmember.

In the depicted embodiment, the extended collar member 515 includes aC-shaped semi-ring that extends about halfway around the neck. Thesemi-ring further comprises a first tang 557 fastened at a first end 552of the semi-ring and extending therefrom. The device 501 includes afirst screw 531 threaded through the first tang 557. The projection 537comprises an elastic pad 539 disposed over an inner tip of the screw. Anouter base of the screw comprises wide, grip-able head 561. Twisting thewide head 561 of the screw when the extended collar member is disposedaround the neck of the patient drives the elastic pad 539 into the neckto restrict flow within the jugular vein. In the depicted embodiment,the semi-ring further comprises a second tang fastened at a second endof the semi-ring and extending therefrom, the second tang having asecond screw threaded therethrough.

FIG. 6 shows the device 501 around the neck of a patient. FIG. 6 showsthe neck collar presuming on a jugular vein (may be controlled usingultrasound). The projection 537 is positioned to press against the spoton the neck that is above a jugular vein, thereby restricting blood flowwithin the jugular vein.

FIG. 7 is a close-up of the device 501 for treating edema, positionedwith respect to an external jugular vein 2191 and an internal jugularvein 2192. The extended collar member 515 extends at least partwayaround a neck of a patient. The projection 537 protrudes inward from aninner surface of the collar member. The projection 537 presses againstthe neck near a jugular vein. The projection 537 may be provided as ascrew threaded through a portion of the collar member. Here, theprojection is provided by a tip of the screw. Twisting a head of thescrew when the extended collar member is disposed about the neck of thepatient drives the projection into the neck to restrict flow within thejugular vein. The tip of the screw comprises an elastic pad.

FIG. 8 shows the elastic pad 539 used to restrict flow. Restricting theflow within the jugular vein causes pressure near an outlet of alymphatic duct to decrease.

FIG. 9 depicts a patient being treated with the device 501 according tothe method 401. Any suitable device 101 may be used to apply pressurethat restricts flow in the vein. Other mechanisms and embodiments arewithin the scope of disclosure. Embodiments may include eccentric discs,inflatable balloons, inflatable collars, or other mechanisms.

FIG. 10 shows a disc-based device 1001 that includes collar pressuremechanism using screws and eccentric discs.

FIG. 11 shows the disc-based device 1001 on a patient.

FIG. 12 is a detailed view of the disc-based device 1001, positionedwith respect to an external jugular vein 2191 and an internal jugularvein 2192. Certain embodiments of a disc-based device 1001 include oneor more screws 1037 extending through an extended collar 1044.

FIG. 13 is a detail view of a screw and disc of the disc-based device1001. The screw 1037 extends through the extended collar 1044. At a tipof the screw is an asymmetric disc 1025, and a projection pad 1093 isseated on the asymmetric disc 1025. Twisting the screw 1037 drives theprojection pad 1093 into a spot on the patient's neck adjacent a jugularvein, thereby restricting flow in the vein.

Other mechanisms and embodiments of the disclosure include inflatableballoons.

FIG. 14 shows a balloon device 1401 that includes an extended collarmember comprising a rigid, C-shaped semi-ring 1409 that extends at leastpartially around the neck. The semi-ring 1409 comprises at least a firsttang 1477 extending from a first end of the semi-ring. A projection 1437protrudes inward from an inner surface of the first tang. Here, theprojection 1437 comprises an inflatable pad 1481, fed by an inflationlumen 1439 and controlled by inflator/handle 1447. The device 1401extends at least partway around a neck of a patient. The projection 1435protrudes inward from an inner surface of the collar member and ispositioned to press against the neck near a jugular vein, therebyrestricting blood flow within the jugular vein.

FIG. 15 shows the balloon device 1401 around the neck.

FIG. 16 shows the balloon device 1409 on the patient.

FIG. 17 is a detailed view of the balloon device 1409, positioned withrespect to an external jugular vein 2191 and an internal jugular vein2192.

FIG. 18 shows the inflatable pad 1481. As shown (e.g., in FIG. 14) theprojection 1435 includes an inflatable pad 1481. Inflating the pad 1481when the extended collar member is disposed around the neck of thepatient drives the pad into the neck to restrict flow within the jugularvein. In other embodiments all or portions of collar or neck cuff arethemselves inflatable.

FIG. 19 shows an inflatable collar 1901 in which a collar pressuremechanism uses an collar member 1915 with elastic biocompatible pads1935 on inflatable portions 1934 of the collar. One or more inflationlumens 1939 are in fluid communication with the inflatable portions 1934and one or more inflation mechanisms (not shown). The inflatable collardevice 1901 for treating edema includes an extended collar member 1915dimensioned to extend at least partway around a neck of a patient. Aprojection 1935 protrudes inward from an inner surface of the collarmember 1915. The projection 1935 may be positioned by a physician topress against the neck near a jugular vein.

FIG. 20 shows the inflatable collar 1901 disposed about the neck.Inflating the portions 19354 when the collar member is disposed aroundthe neck of the patient drives the projection 1935 into the neck torestrict flow within the jugular vein.

FIG. 21 shows positioning for the inflatable collar 1901. The dottedlines show the positions of the projections 1935 when the collar 1901 isnot inflated. When the collar 1901 is inflated, the projections 1935 adriven into the skin, to the positions shown by the solid lines. Alsodepicted are locations of the external jugular vein 2191 and an internaljugular vein 2192

FIG. 22 shows the projection 1935.

In other embodiments, the disclosure provides a device for treatingedema in which an extended collar member extends at least partway arounda neck of a patient and presses a projection against the neck near ajugular vein and in which the collar member self-fastens or is enclosedin a cuff that self-fastens.

FIG. 23 shows a tightening cuff style fastening device 2301 in which acollar pressure mechanism uses a pressure tightening mechanism. Thedevice 2301 includes an extended member 2344 that positions one or moreprojections 2309 at a spot on a neck of a patient adjacent a jugularvein.

FIG. 24 shows the device 2301 in place, with the extended member 2344being substantially covered by tightening cuff 2392. The tightening cuff2393 can be squeezed tight through a series of clicks, e.g., due to aplastic detente mechanisms along a strap that slides through a receiverwith a ratchet prong. Thus the extended member 2344 is provided with thetightening cuff 2392, which has a releasable fastening mechanismdefining a plurality of stops corresponding to progressively tighterfittings, such that cinching the extended collar mechanism closed drivesthe projection into the neck to restrict flow within the jugular vein.The tightening cuff device 2301 may be tightened by any suitablemechanism including, for example, a slider and clicker, a plunger andladder, male to female connectors, a cable tie-style fastener, a latch,and electronic sliding device, which may be controlled or not by acontroller.

FIG. 25 shows the tightening-cuff 2392 in place on a patient. Thetightening of the tightening cuff 2392 creates a restriction in a veinsuch as the internal jugular vein.

FIG. 26 shows a projection 2309 included in the tightening cuff stylefastening device 2301. Other embodiments are within the scope of thedisclosure.

FIG. 27 shows a limb-cuff device 2701 for reducing the CVP byrestricting externally one or both of the femoral veins. The limb-cuffdevice 2701 includes an extended, closeable strap 2702 with at least oneprojection 2755 protruding therefrom.

FIG. 28 shows a patient with the limb-cuff device 1701.

FIG. 29 shows the limb cuff device 2701 disposed with respect to afemoral vein 3991, as well as a long saphenous vein 3992 and tributaries3663 of long saphenous vein.

FIG. 30 is a close-up of the limb cuff device 2701 on a patient. Thelimb cuff device 2701 operates as an external adjustable cuff forpartially or fully restricting the jugular or femoral vein. The limbcuff device 2701 may operate by pressing on a femoral vein and may becontrolled by ultrasound. The limb cuff device 2701 may fit to the leftor right femoral vein. The limb cuff device 2701 may be tightened by anysuitable mechanism such as screws, scotch bundling wrap, rotating aneccentric disk, pressure pad inflation, leg device inflation (i.e.,inflate the limb cuff device 2701), slider and clicker, plunger andladder, male to female connectors, a cable tie, a latch, or anelectronic sliding device (controlled or not by a controller).

FIG. 31 shows a projection 2755 for the limb cuff device 2701. Theprojection 2755 may be an elastic pad. Other embodiments are within thescope of the disclosure.

FIG. 32 shows a deployable stent device 3201 for treating edema. The adeployable stent device 3201 is shown in an un-deployed configuration. Acollapsed basket stent 3211 is contained within a catheter 3203 attachedto a distal portion of a pushable wire 3225. When the catheter 3203 isretracted relative to the pushable wire 3224, a shape-memory material ofthe basket stent 3211 causes the basket stent to assume a deployedconfiguration.

FIG. 33 shows the deployable stent device 3201 in a deployedconfiguration. The deployable stent device 3201 provides a device forreducing pressure by restricting the vein internally using a Nitinolstent graft with an adjustable restrictor to the flow through it. Insome embodiments, the basket stent 3211 does not have an un-deployedconfiguration as shown in FIG. 32, but instead is fully expanded, andsliding the catheter 3203 with respect to the pushable wire 3225 deformsthe basket stent 3211 adjusting a porosity therethrough.

As an example of an intravenous flow restrictor, a catheter can beinserted via a central line placement technique and advanced a few cminto the vein. A partial restriction can be performed using a balloonthat opposes the vein and leaves an internal pathway for the blood.

Another indwelling intravenous apparatus can be a balloon and a shaftwith longitudinal openings that can be adjusted relative to anintroducer sheath and thus control the flow through the restrictor.

FIG. 34 shows an open-sheath device 3401 for treating edema. Theopen-sheath device 3401 includes a balloon 3425 and a shaft, or sheath3444, with longitudinal openings 3491 that can be adjusted relative toan introducer catheter 3409 and thus control the flow through therestrictor. The catheter 3409 preferably includes an inflation lumen3455 allowing a user to expand the balloon 3425 and control theopen-ness of the openings 3491, thereby controlling flow through theopen-sheath device 3401. In methods of the disclosure, the open-sheathdevice 3401 is introduced into a blood vessel of a patient, preferably ajugular vein. The open-sheath device 3401 is navigated so that it isnear an outlet of a lymphatic duct. The balloon 3425 is inflated and thesheath 3444 restricts flow, thereby creating a low-pressure zone nearthe outlet of lymphatic duct. This causes lymph to drain from thelymphatic system to the circulatory system, thereby relieving edema.

Device and methods of the disclosure may use other features andconfigurations. On devices such as the open-sheath device 3401, one ormore pressure sensor distally and/or proximally to the balloon 3425 canbe used to regulate the pressure in the part of the vein that extendsfrom the balloon to the right atrium. Typically, the pressure range thatwould be desired to achieve is 0-5 mm Hg but lower pressures down to −5mm Hg may be favorable. The restriction can be done for long duration ofseveral days to enable edema fluid removal. The restriction can be leftindwelling or externally deployed for longer durations of weeks andmonths and deployed a few hours each day to prevent ADHF episodes fromoccurring.

Other embodiments are within the scope of the disclosure.

FIGS. 35-44 show an intravascular restriction device 3501 that uses aninternal balloon with a restrictor to fully or partially restricting avein

FIG. 35 shows the restriction device 3501 in a jugular vein of apatient.

FIG. 36 shows the restriction device 3501, useful for reducing pressureby restricting the vein internally using a balloon with an adjustablerestrictor to the flow through it. The restriction device 3501preferably includes an extended catheter shaft 3525 with a balloon 3509on a distal portion. An inflation port 3537 may be provided to inflatethe balloon 3509.

FIG. 37 is a close-up of the balloon 3509 of the restriction device3501. The device 3501 optionally includes a pressure-sensing mechanism3514 such as a pressure-sensing lumen or mechanical pressure sensor.

FIG. 38 is a cross section through the restriction device 3501.

FIG. 39 is a cross-section across the catheter shaft 3525 of therestriction device 3501.

FIG. 40 shows the restriction device 3501 in vasculature of a patient. Apressure sensor may be located on the device 3501. Blood flows throughthe device, and inflation of the balloon modulates a diameter of aninternal flow tunnel defined through the balloon, thereby controllingflow.

FIG. 41 is a close up of the restriction device 3501 in the vasculatureof the patient. Other embodiments are within the scope of thedisclosure.

FIG. 42 depicts a collapsible tube device 4201 for treating edema. Thecollapsible tube device 4201 includes a catheter 4211 carrying a balloon4215 connected to a collapsible tube 4219. A distal portion 4225 of thecatheter 4211 has a tip 4227. The collapsible tube device 4201 may beused as a self-regulating flow restrictor comprised of a catheter 4211with hollow balloon 4215 which is attached to a collapsible tube 4219.

FIG. 43 shows the balloon 4215 of the collapsible tube device 4201.

FIG. 44 shows the collapsible tube device 4201 located within a vessel4401 of a patient. The catheter tip 4227 is directed toward the heart.

As shown, P2 is the central venous pressure (CVP) near the heart. Thecentral venous pressure is known to be pulsatile due to heart valvesfunction and respirations. P3 is the pressure within the collapsibletube and P1 is the upstream blood pressure. When P3<P2 the tubecollapses and prevents flow.

Looking at FIG. 44, note that the balloon 4215 prevents flow in an outerportion of the vessel 4401. Thus, any blood flowing through the vessel4401 must flow through the collapsible tube 4219. A cross-sectional areaof the collapsible tube 4219 is smaller than a cross-sectional area ofthe blood vessel 4401.

As the collapsible tube 4219 has smaller cross section than the vessel4401, and due to mass conservation, the flow velocity in the collapsibletube 4219 is higher than the flow velocity in the vein 4401. Therefore,due to energy conservation and according to the Bernoulli principle, thepressure inside the collapsible tube P3 is smaller than the upstreampressure P1. For certain diameters of the collapsible tube 4219, thepressure inside the collapsible tube can be within the range of thecentral venous pulsatile pressure.

When the central venous pressure P2 is higher than P3 the tube collapsesand flow is halted.

This in turn causes reduction in the central venous pressure. When thecentral venous pressure reduces below P3 the flow through therestriction is resumed.

FIG. 45 shows a graph of central venous pressure (CVP).

FIG. 46 illustrates average CVP being higher than P3.

If the average CVP is higher than P3, the episodes of tube collapse willbe longer and thus in turn will generate bigger reduction in the CVP.Such pulsatile restriction can also contribute to elimination of flowstagnation areas and thus reduce the risk of thrombus formation. Invarious embodiments, the restriction can either be total or partial. Inpreferred embodiments, the level of restriction is adjusted and pressuremonitored until the required CVP is obtained to levels between −5 mm Hgto +5 mm Hg.

The disclosure provides methods and device for the treatment of edemawith embodiments disclosed for the application to an outside of a bodyand invasive embodiments included in the disclosure. In certainpreferred embodiments, the disclosure provides devices for treatingedema. The devices include an extended collar member dimensioned toextend at least partway around a neck of a patient and a projectionprotruding inward from an inner surface of the collar member, theprojection positioned to press against the neck near a jugular vein,thereby restricting blood flow within the jugular vein. Devices of thedisclosure may further include one or more pressure sensing transducersto monitor the CVP and control the restrictions. Devices and methods ofthe disclosure may be used for reducing venous pressure and rightventricular end diastolic pressure. Preferably, devices and methods ofthe disclosure are used for reducing the pressure in the outflow of thelymphatic ducts and consequently enhancing lymphatic return in fluidoverloaded patients. Devices and methods of the disclosure arebeneficial for reducing pressures in the renal veins and improving flowacross the kidneys and therefore improving urine output in fluidoverloaded patients.

Certain embodiments include systems and methods that combine an internaldevice with an external device and use the internal device and theexternal device in combination. External devices include the device 101,the screw-based device 501, the disc-based device 1001, the balloondevice 1401, the inflatable collar 1901, the tightening cuff stylefastening device 2301, and the limb-cuff device 2701. Internal devicesinclude the deployable stent device 3201, the open-sheath device 3401,the intravascular restriction device 3501, and the collapsible tubedevice 4201. Thus, certain aspects of the disclosure provide a system orkit for treating edema, wherein the system or kit includes an internaldevice and an external device. The internal device and the externaldevice may each be, for example, any one of those embodiments disclosedherein. Related aspects provide a method thus uses such a system or kitfor the treatment of edema.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

Various modifications of the invention and many further embodimentsthereof, in addition to those shown and described herein, will becomeapparent to those skilled in the art from the full contents of thisdocument, including references to the scientific and patent literaturecited herein. The subject matter herein contains important information,exemplification and guidance that can be adapted to the practice of thisinvention in its various embodiments and equivalents thereof.

What is claimed is:
 1. A method of draining lymph, the methodcomprising: restricting flow through a jugular vein of a patientaffected by heart failure or edema by applying pressure to a neck of thepatient at a spot on the neck proximal to the jugular vein with amedical device for treating edema, the medical device comprising: anextended collar member dimensioned to extend at least partway around theneck, a screw threaded through a portion of the collar member, and aprojection provided by a tip of the screw protruding inward from aninner surface of the collar member and positioned to press against thespot on the neck, wherein the method includes twisting a head of thescrew when the extended collar member is disposed about the neck of thepatient to drive the projection into the neck to restrict flow withinthe jugular vein, thereby decreasing pressure at an outflow of alymphatic duct.
 2. The method of claim 1, further comprising imaging atleast a portion of the jugular vein with a medical imaging instrumentand using the imaging while applying the pressure to the spot on theneck.
 3. The method of claim 1, further comprising restricting flowthrough the jugular vein by applying, with the projection, pressure tothe jugular vein.
 4. The method of claim 3, wherein restricting the flowthrough the jugular vein creates a local decrease in pressure within thejugular vein near the outlet of a lymphatic duct.
 5. The method of claim1, wherein the extended collar member forms a neck cuff that fastensaround the neck.
 6. The method of claim 1, wherein the extended collarmember includes a C-shaped semi-ring that extends about halfway aroundthe neck.
 7. A method of draining lymph, the method comprising:creating, within a jugular vein, a local decrease in pressure near anoutlet of a lymphatic duct by applying pressure to a neck of the patientat a spot on the neck proximal to the jugular vein using a medicaldevice for treating edema, wherein the device includes: an extendedcollar member dimensioned to extend at least partway around the neck, ascrew threaded through a portion of the collar member, wherein a tip ofthe screw provides a projection protruding inward from an inner surfaceof the collar member, the projection positioned to press against thespot on the neck, wherein the method includes twisting a head of thescrew when the collar member is disposed about the neck of the patientto drive the projection into the neck to restrict flow within thejugular vein, thereby causing lymph to drain from interstitium and intoa venous system of a patient.
 8. The method of claim 7, wherein theextended collar member forms a neck cuff that fastens around the neck.9. The method of claim 7, wherein the extended collar member includes aC-shaped semi-ring that extends about halfway around the neck.